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Kronos Early Estrogen Prevention Study (KEEPS)

Information source: Kronos Longevity Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause; Arteriosclerosis

Intervention: Conjugated equine estrogens 0.45 mg/day (Drug); Transdermal estradiol, 50 mcg/day (Drug); Micronized progesterone, 200 mg/day x 12 d/month (Drug); CEE , progesterone, estradiol patch or placebo for each (Drug); CEE, progesterone, transdermal patch or the placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Kronos Longevity Research Institute

Official(s) and/or principal investigator(s):
S Mitchell Harman, MD, PhD, Study Director, Affiliation: Kronos Longevity Research Institute
Frederick Naftolin, MD, PhD, Study Director, Affiliation: Kronos Longevity Research Institute
Michael Mendelsohn, MD, Principal Investigator, Affiliation: Tufts Medical Center
Howard Hodis, MD, Principal Investigator, Affiliation: University of Southern California
Matthew Budoff, MD, Principal Investigator, Affiliation: University of California, Los Angeles
Sanjay Asthana, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
Dennis M Black, PhD, Principal Investigator, Affiliation: University of California, San Francisco

Summary

The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.

Clinical Details

Official title: Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Rate of change of carotid intimal medial thickness by ultrasound

Secondary outcome:

Change in coronary calcium score by X-ray tomography

Plasma lipid profiles

Blood clotting factors

Serum inflammatory factors

Hormone levels

Cognitive and Affective scores on standard psychometric tests

Quality of life

Detailed description: The KEEPS is designed to explore the hypothesis that early initiation of hormone therapy, in women who are at the inception of their menopause, will decrease the rate of accumulation of atherosclerotic plaque, indicating a likely delay in the onset of clinical cardiovascular disease. The study is designed as a multicenter, 4 year randomized clinical trial. It will evaluate the effectiveness of of 0. 45 mg/day of oral conjugated equine estrogens or 50 mcg/day of transdermal estradiol via skin patch changed weekly (each in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month), versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the accrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment. A number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease, and effects on cognition will also be studied. The study will enroll a total of 720 women in 2005-6, with an anticipated completion of the trial in 2010.

Eligibility

Minimum age: 42 Years. Maximum age: 58 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- menses absent for at least 6 months and no more than 36 months

- good general health

- plasma FSH level greater than or equal to 35 mIU/ml

- estradiol levels < 40 pg/ml

- normal mammogram within 1 year of randomization

Exclusion Criteria:

- use of hormone replacement or supplement within 3 months of randomization

- endometrial thickness >5 mm by vaginal ultrasound

- in utero exposure to diethylstilbestrol (DES)

- current smoking > 10 cigarettes/day

- obesity-body mass index > 35

- history of clinical cardiovascular disease

- history of cerebrovascular disease

- history of thromboembolic disease

- coronary calcium score ≥ 50 units

- dyslipidemia-LDL cholesterol >190 mg/dl

- hypertriglyceridemia-triglycerides >400 mg/dl

- lipid lowering medication (statin, fibrate,or > 500 mg/day of niacin)

- nut allergy (Prometrium includes peanut oil)

- uncontrolled hypertension-systolic BP >150 and/or diastolic BP > 95

- hysterectomy

- history of, or prevalent, chronic diseases including any cancer (other than basal

cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease

- known HIV infection and/or medications for HIV infection

- results of any safety laboratory test chemistries, (TSH, CBC, U/A) more than 20%

abnormal

Locations and Contacts

Kronos Longevity Research Institute, Phoenix, Arizona 85016-3452, United States

University of California, San Francisco, San Francisco, California 94115, United States

Yale University Medical Center, New Haven, Connecticut 06519, United States

Brigham and Women's Hospital, Boston, Massachusetts 02215, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Albert Einstein College of Medicine, Bronx, New York 10461, United States

Columbia Presbyterian Hospital, New York, New York 10032, United States

University of Utah, Salt Lake City, Utah 84108, United States

University of Washington/VA Puget Sound, HCS, Seattle/Tacoma, Washington 98493, United States

Additional Information

Information on hormone treatment and KEEPS rationale

Information on sponsoring institution

Related publications:

Harman SM, Naftolin F, Brinton EA, Judelson DR. Is the estrogen controversy over? Deconstructing the Women's Health Initiative study: a critical evaluation of the evidence. Ann N Y Acad Sci. 2005 Jun;1052:43-56.

Harman SM, Brinton EA, Cedars M, Lobo R, Manson JE, Merriam GR, Miller VM, Naftolin F, Santoro N. KEEPS: The Kronos Early Estrogen Prevention Study. Climacteric. 2005 Mar;8(1):3-12.

Harman SM, Brinton EA, Clarkson T, Heward CB, Hecht HS, Karas RH, Judelson DR, Naftolin F. Is the WHI relevant to HRT started in the perimenopause? Endocrine. 2004 Aug;24(3):195-202.

Starting date: September 2005
Last updated: September 10, 2009

Page last updated: August 23, 2015

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